Regulatory Compliance Specialist

1 week ago


Oxford, Oxfordshire, United Kingdom Pharma Partners Recruitment Ltd Full time
Job Description

We are seeking a highly skilled Quality Assurance Manager to join our team at Pharma Partners Recruitment Ltd.

About the Role

The successful candidate will be responsible for the coordination and management of our Quality Management System (QMS). This will involve ensuring compliance with regulatory requirements, internal policies, Standard Operating Procedures, and industry standards.

Key Responsibilities

  • Act as the primary point of contact for the business in matters related to the operation of the QMS.
  • Develop and implement metrics, measures, and reports for the operation of the QMS.
  • Oversight and coordination of quality-related activities, including change controls, deviations, CAPAs, product quality reviews, complaints, and self-inspections.
  • Author and implement QMS procedures.
  • Prepare and manage finished product labeling and patient information leaflets.
  • Plan and conduct internal audits and self-inspections.
  • Provide advice and encouragement to staff to ensure individual and company compliance.
  • Provide training to staff on general or specific quality topics.
  • Support the QA team in relation to quality investigations and initiatives.
  • Prepare, manage, and present materials for Quality Management Review.
  • Contribute to continuous improvement activities and take ownership of continuous improvement tasks and projects.

Requirements

  • At least 2 years' experience in the operation of quality systems in a pharmaceutical quality-related role.
  • Experience of working within sterile pharmaceutical manufacturing and/or radiopharmaceutical manufacturing is desirable but not essential.
  • Proactive approach and can-do attitude.
  • Excellent written, verbal, and presentation skills.
  • Excellent organizational skills.
  • Excellent IT skills for standard desktop packages (experience with Power BI desired but not essential).
  • Good analytical skills.
  • Competent in problem-solving, team building, planning, and decision-making.
  • Sound knowledge of GMP and/or GCP.

Qualifications

  • A degree in a science-related discipline.

Reporting to

  • Associate Director, Quality Operations.

Flexible Working

  • Flexible working available with the requirement to be onsite twice a week.

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